The O&P industry’s innovative developments have helped thousands in the United States and hundreds of thousands worldwide. John Michael, MEd, CPO, FAAOP, acknowledged the success of the many technological advances in the O&P industry, especially in the past 10 to 15 years. He cited two products that are currently in the pipeline – the propulsive motorized foot and the electronic hand with individually moving digits – as signs that the industry is moving forward. Yet, economic and reimbursement barriers also have Michael worried that these advances will come to a halt. Could the combination of a complicated reimbursement process and the economic downturn create a technological drought in the O&P industry?
In the O&P industry, there is one eye on the future and one eye on the economy. Realistically, product development takes 3 to 5 years. A product or material out on the market today is relatively safe. A product in the market today was invested in, researched and improved upon years ago before the economic crisis, according to Michael.
However, in Michael’s view, it is too soon to know if the struggling economy will have an impact on the O&P industry in the long term.
“Whatever is going to be developed and released is going to be in the pipeline for years,” Michael said. “Now if the downturn is protracted, you are going to see a drought 5 years from now. The short-term economy does not directly effect private research in terms of what’s emerging now but it does impact their investment in future research. That’s what worries me.”
A drought would mean today’s technology will be frozen and clinicians and practitioners will be using the same techniques with the same technology and the same limitations years from now.
The O&P industry’s ability to survive the economic crisis is due to the fact that health care is vitally important and usually stable. Put simply, there will always be business.
“Health care, because it is such an essential service, tends to move forward despite economic conditions,” Michael said. “It doesn’t accelerate when it’s really good and doesn’t decelerate when it’s really bad.”
Bill Wilcox, RTP, owner of Custom Fit Manufacturing Advisors, believes the O&P industry has slowed down due to the economic downturn.
“In my opinion, the way the economy is right now, it has affected the O&P community,” Wilcox said. “The [patient’s] out of pocket expenses through their insurance companies and the changes in health care reimbursements have slowed down the field dramatically.”
Wilcox pointed out that people are now willing to wear their prosthesis for longer periods of time. Rather than buying a new prosthesis, patients are buying more socks or less expensive O&P products.
Jon Shreter, CPO, president of Allied O&P, has found business to be a little slower than usual, but nothing too drastic.
“As far as the economy is concerned, things are a little slower but I don’t think it has affected us too much,” he said.
Despite economic uncertainty, practitioners have their suggestions for the future of O&P technology.
“Where the industry should be moving is toward thermoplastics,” Wilcox said. “There really hasn’t been a lot of experimentation and research on thermoplastics. It is used a lot, but to be able to utilize thermoplastics in a revolutionary new way is still pretty far out there.”
In his article, Lower Extremity Thermoplastics: An Overview, that appeared in the Journal of Prosthetics and Orthotics, William Clover Jr. described the characteristics of thermoplastics.
“Clarity, flexibility, rigidity, faster processing times, localized adjustment by the use of heat, inert material and surface quality are just a few of the benefits associated with thermoplastics,” Clover wrote.
If thermoplastics contain all of those qualities, why is it not being used more often in new products?
“When you get into thermoplastics, you start pulling away from the cosmesis side,” Wilcox said. “You just don’t get the variety of colors as you would with resin.”
When dealing with a patient, the practitioner needs to look at three different things, according to Wilcox. The device needs to fit correctly, it needs to function properly and it needs to satisfy the patient cosmetically. Thermoplastics have yet to be used in a way that satisfies the patient’s need for a cosmetically appealing device.
“That is sort of the weakness in all of these systems,” Shreter said. “There is nothing we can just snap into place. The covers are very frustrating because they hide all the technology, which is good, but to service the technology, it’s difficult.”
In Shreter’s view, once a prosthetist produces a cover for a device, it is time consuming to get the cosmesis back again.
“One of the things we were looking for and came close to finding was a thermoplastic that was on the inside, laminated on the outside and had the ability to be thermoformed,” Wilcox told O&P Business News. “If there was an area that was bothering the patient, then it can be heated up and pushed up or in without compromising the integrity of the socket.”
Unfortunately the thermoplastic and the lamination would separate when it was heated deeming it cosmetically unappealing.
“If you could get a lamination resin that would melt and become part of the plastic then you have something,” Wilcox said.
“We’re starting to see external power come into play,” Shreter said. “Powered orthoses and powered knees, I think that’s where it is going. We’re going to where it’s almost like a robotic system. Where there is no power for that muscle, then we’ll be providing that power.”
One of the key components for powered orthoses is the battery. Shreter believes the battery is the limiting factor in this advanced technology.
“I was at a conference and there were a couple of companies that make batteries and they are experimenting now with fabrics that use a battery,” Shreter said.
Instead of having a square battery, part of the garment is the battery. The patient would wear a vest and the vest would be the battery for the powered orthoses. Instead of walking around with a five-pound power pack, the weight of the battery would be distributed over a greater area of the body. A battery that weighs five pounds in one area will feel differently than a vest that weighs five pounds over a greater area. The idea is to have the whole garment store energy.
“This is pretty exciting because [the battery] will be incorporated into the actual fabric,” Shreter said. “The whole matrix of the device could act as a battery, if they can figure out how to make the plastics or the fabrics store energy.”
Wilcox also expect big changes for orthesis wearers.
“Orthotic-wise, for the lower limb, I think you are going to see more and more of that coming out,” Wilcox said. “I think that is something on the horizon for lower limb orthotics.”
Along the same lines as the powered orthosis, Michael is intrigued by the propulsive ankle foot device. The propulsive motorized foot has the potential to be the next wave beyond the electronic ankle that the O&P industry currently boasts.
“I think there are some very interesting lab results with an actively propulsive ankle-foot mechanism,” Michael said. “If that is done effectively, I think that would represent the quantum leap in lower limb prosthetic function. Like all technologies, they are going to face the reimbursement barrier.”
Pre-Impregnated carbon fiber
Kevin Barnes, BOC/P, RTP, upper extremity prosthetist for Prosthetic and Orthotic Solutions Inc., described pre-impregnated carbon fiber, also referred to as pre-pregs, as a new technology that, while not mainstream, is more accurate and can be better targeted for specific need. According to Barnes, pre-pregs require a higher degree of engineering than is traditionally performed. It takes more thought to determine where you want the strength and flexibility.
“The pre-pregs allow you to actually engineer the strength, rigidity and flexibility to where you need it more specifically,” Barnes said. “The pre-preg is a more accurate way of getting a resin to substrate ratio.”
According to the Barnes, once the resin is flowing, good technicians will remove the excess resin but the device will still be fairly saturated.
“Pre-pregs are much closer to a 50/50 resin to fabric ratio,” Barnes said. “That’s the more optimal weight to strength ratio.”
Barnes believes the current carbon fibers are probably over-designed and the carbon weaves or the fiberglass materials that Barnes generally uses are heavyweight.
“There’s no substitute for clinical experience,” Michael said. “That’s where we knock off the rough edges. That’s where we give out clinical feedback to our developers who then redesign it to second, third and fourth generations that become more reliable, effective and useful to the patients.”
Michael points out that pre-preg custom carbon fiber orthoses are routinely provided in Germany. He believes they are stronger, thinner, lighter and more versatile, than the carbon fiber the United States provides. Unfortunately, the German pre-preg is never reimbursed in the United States.
We are aware of the technology. There are a few people that sort of do it despite the financial barriers primarily for a very limited population of patients that have very good coverage or who can pay out of pocket,” Michael said.
Michael explained that it is extremely difficult to get reasonable reimbursement for the fibers that were good 20 years ago, let alone for new innovative carbon fibers of today.
The complex and intricate nature of granting L-codes and gaining reimbursement has proven to be a major barrier for companies and private researchers who are creating new products in the O&P industry. The frustrating process of reimbursement has cut short many innovative developments in the industry.
“For a long time it was impossible to be reimbursed, now I think it’s challenging,” Michael said. “One of the biggest barriers is Medicare’s steadfast refusal in the last decade to grant L-codes for any new innovative orthoses or prostheses.”
Without reasonable reimbursement, there is no way of knowing if the technology can compete in the marketplace.
“Most material advancements in our field are done by private research, often by clinical research by frontline caregivers,” Michael explained. “But if you can’t get reimbursed for technology of 20 years ago, then it is very discouraging to move forward and use the technology of today or tomorrow.”
Barnes contends that more progressive practices will simply eat the cost of the product and sacrifice their own bottom lines. They would take the hit for two reasons. First, the product can become beneficial for the patient. Secondly, they want to continue further along in development.
“If we don’t use the current cutting edge technology, especially with the current reimbursement barriers we’re facing, then we’re never going to get the next generation,” Michael said. “So we kind of have to reward those who took the risk and developed advanced technology despite the system in order for them to take that risk again.”
For more information:
- Clover, William Jr. Lower extremity thermoplastics: an overview. Journal of Prosthetics and Orthotics. 1991; 3:9.
Anthony Calabro is a staff reporter for O&P Business News.
This story includes a small representative sample of individual companies and products. O&P Business News does not intend to promote individual companies or their products, nor to achieve an industry-wide consensus on the issue. Companies contacted in developing this story were randomly selected.